Research With Humans

Contact the ORC

Office of Research Compliance
Division of Research and Sponsored Programs
Suite 207, Schwartz Center
(330) 672-2384researchcompliance@kent.edu

Before you implement research that involves the use of human subjects, the protocol must be reviewed and approved by a Kent State Institutional Review Board (IRB). The Kent State IRB is responsible for ensuring that the research adequately protects the rights and welfare of study participants. The activities of the IRB are coordinated and administered by the Office of Research Compliance (ORC).

How to Determine if Your Research Needs IRB Review

The federal regulations for the Protection of Human Subjects define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (45 CFR 46.102.d)

“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” (45 CFR 46.102.f)

Types of Review

There are three levels of review for research involving the use of human subjects as defined in the Department of Health and Human Services regulations (45 CFR 46). IRB reviewers make the final decision for the level of review that is needed.

Exempt from annual review (level I)

This type of review is required for studies that meet exemption categories as defined by 45 CFR 46. Protocols deemed exempt by the IRB are not subject to continuing review and do not expire. The ethical principles of research conduct still apply to studies deemed exempt from annual review. To make changes to the research design after the IRB has reviewed the protocol as exempt, you must submit an amended form to the ORC to ensure that the changes do not disqualify the study from exemption. If you think that your project meets the exemption categories, complete a Level I – Exempt from Annual Review application and append it with the supporting documents (CITI completion certificate, instruments, etc.). Do not begin data collection until you have received an emailed approval from the IRB.

Expedited review (level II)

These applications are reviewed by the IRB chair or at least one other IRB reviewer designated by the chair. This type of review is required for studies that involve minimal risk and fit into an expedited review category of research as defined by 45 CFR 46 and the FDA regulations (Title 21 CFR 312.3; 21 CFR 812.3). If you believe that your research project falls into the expedited research categories, complete a Level II/III – Use of Human Subjects in Research Application. Do not begin data collection until you have received written approval from the IRB.

Full board review (level III)

This type of review is required for protocols that pose greater than minimal risk to subjects or involve minimal risk and do not qualify for expedited review. Full board review means that the research is reviewed at a convened meeting at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. If you believe that your research project falls into the expedited research categories, complete a Level II/III – Use of Human Subjects in Research Application. Do not begin data collection until you have received written approval from the IRB.

If your study has been identified as requiring a full board review, the ORC will contact you by email to ask you to attend a committee meeting. Please be prepared to discuss the project and address comments or questions from IRB members. Students conducting research for their thesis or dissertation should accompany their faculty adviser (who serves as the Principal Investigator on the IRB application) to the IRB meeting.

Examples of research that needs full board review include, but are not limited to:

Research involving deception

Research involving prisoners (e.g., individuals in prisons, halfway houses and certain parolees, such as those residing in a treatment facility as a condition of parole)

Some types of research with children (<18 years old), for example, if a waiver of parental consent is requested

Research with other vulnerable populations (e.g., institutionalized individuals, pregnant women)

Research presenting more than minimal risk

Overview of the Process

At Kent State, the IRB application submission and approval process requires collaboration among the investigator, IRB reviewer(s) and the ORC. Investigators send a completed IRB application and required submission materials (instruments, informed consent document(s), training certificates, applicable appendices, etc.) to an IRB discipline-specific reviewer by email. The application is reviewed for completeness, methods and adherence to ethical standards. The reviewer communicates any needed revisions to the Investigator(s) by email. This process continues until the discipline-specific reviewer is able to make a recommendation for approval. The IRB reviewer then sends the application and materials to the ORC for logging, final review and administrative processing. After approval is granted by the IRB, the ORC sends an approval email to the investigator.

Required Training

Before beginning research that involves the use of human subjects, investigators and key personnel must complete an online Collaborative Institutional Training Initiative (CITI) course. The CITI training completion certificate must be included with your IRB application submission materials before IRB review can be completed. Please note that failing to include your completion certificate with your submission materials may delay gaining approval for your study.

Approval Timeline

Different types of studies have different timetables for review. For example, expedited and exempt studies are reviewed as received by the ORC. Exempt from Annual Review studies, posing minimal risk to human subjects, take approximately one to three weeks to be approved from the time that the protocol is logged into the ORC database. Approval for expedited studies can take approximately two to six weeks. The timeline for final approval can vary depending on the volume of applications that are being submitted and their completeness.

It is important to remember that after review by an IRB member, both exempt and expedited studies are reviewed “in house” at the ORC, and the full board does not typically review them. Therefore, the full board meeting and agenda dates and deadlines are not applicable to exempt and expedited studies. Full board studies are reviewed twice per month during the academic year and once per month during the summer. Typically, notification of the determinations reached at the full board meetings are emailed to investigators within two weeks after the meeting date.

Submission Deadlines

IRB applications requiring full board review should be submitted to the ORC no later than 10 working days before an IRB meeting. For new submissions, we cannot guarantee review by a particular committee, regardless of the submission date. Assignment of new submissions to an IRB can depend on the nature of the research and the number of studies already assigned to that board. Should you have a request, contact the ORC at researchcompliance@kent.edu and we will do our best to accommodate you.

Review and approval for exempt and expedited research is ongoing. There are no deadlines for initial reviews and investigators are not required to attend the IRB meetings.

Meetings are held in Schwartz Center, Conference Room 203. Please note that if you are a student conducting research for your dissertation or thesis, you must be accompanied by your faculty adviser (who serves as the PI on the research) when attending an IRB meeting.